Sr Quality Engineer

3 days ago


Marlborough, United States US Tech Solutions Full time

Contract: 06 Months Contract


Job Purpose

Responsible for providing technical acumen and data analysis for the Endoscopy division of Boston Scientific for Post Market Reporting assessments (Periodic Safety Updates). The Engineer will have previous experience in PMS activities or equivalent. The analysis and reporting directly supports product sustainment activities assessing product performance for trends including signal escalation. The role identifies, analyzes, helps to investigate, monitors and documents trends at a product performance level for post marketing surveillance data as part of the EU MDR reporting requirements. The role communicates and educates management, R&D, marketing, Design Assurance, plant QA, clinical, and other departments, as well as potentially external customers about complaints monitoring trending and product performance.


Key Responsibilities

· Work as part of the Post Market Surveillance Team in the development and generation of post market surveillance (PMS) plans and reports for Boston Scientific medical devices.

· Collect, analyze, trend and report on safety data to proactively identify potential adverse safety risks or performance trends.

· Provides clinical and safety data assessment of post-marketing events.

· Collaborate with internal functions (Quality, Regulatory, Medical Affairs, Complaint Management, Manufacturing and R&D) to ensure compliance to applicable regulations, standards, and company procedures to help improve the quality of patient care.

· Assist with Risk Management File Maintenance where necessary.

· Support any additional EU MDR quality related tasks as required by BSC


Quality Systems Duties and Responsibilities:

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.


Qualifications

• Bachelor's degree with an Engineering or Science background

• 5+ years of Medical Device engineering experience with BS, 3+ years with MS

• Previous experience with PMS activities or equivalent

• Must have Microsoft office skillset

• Excellent communication


About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.


US Tech Solutions is an Equal Opportunity Employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.


Recruiter Details:

Name: Swati

Email: swati.tiwari@ustechsolutionsinc.com

Internal Id: 24-27449


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